The quest for better validation: a critical comparison of the AAMI and BHS validation protocols for ambulatory blood pressure measurement systems.

Two validation procedures are currently available for the evaluation of ambulatory blood pressure measurement systems--the standard of the Association for the Advancement of Medical Instrumentation (AAMI) and the protocol of the British Hypertension Society (BHS). Both are in the process of revision. Four systems for measuring 24-hour ambulatory blood pressure--SpaceLabs 90207, Novacor DIASYS 200, Del Mar Avionics Pressurometer IV, and Takeda TM-2420--were evaluated according to the BHS protocol, which incorporates many of the features of the AAMI standard, under similar conditions by the same personnel and in the same subjects, so as to examine the relative merits of the two evaluation procedures. Three recorders of each model were subjected to a before-use inter-device variability test, followed by an in-use phase and an after-use inter-device variability test. The main validation test was carried out in 86 subjects with a wide range of pressures, the results being analyzed according to the BHS grading system and the AAMI validation criteria. The SpaceLabs 90207 and the DIASYS 200 achieved B and C grades, respectively, according to the BHS protocol and also satisfied the AAMI criteria for accuracy. The Pressurometer IV achieved a Grade C rating for systolic pressure and a Grade D rating for diastolic pressure and the Takeda TM-2420 achieved Grade D ratings for both systolic pressure and diastolic pressure. Both these devices failed to fulfil the AAMI criteria for accuracy and both failed to function in the main validation test and had to be replaced.(ABSTRACT TRUNCATED AT 250 WORDS)